Drug product
Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0064-30
D-0921-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 5443 vials
- Official record key
drug-enforcement:D-0921-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: B24C21-22 BUD: 8/21/2022, B24B21-22 BUD: 8/21/2022, A24010-22 BUD: 7/10/2022, A24110-22 BUD: 7/10/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility